NCT01775163

Brief Summary

The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study. We aim to determine if changes in energy metabolism might explain why people don't lose the expected amount of weight in an exercise program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

4.2 years

First QC Date

January 22, 2013

Last Update Submit

August 23, 2021

Conditions

Keywords

EnergyMetabolismWeight LossExercise

Outcome Measures

Primary Outcomes (1)

  • Change in 24h energy expenditure

    24h energy expenditure will be measured in a room calorimeter before and after a 24 week exercise program

    24 weeks

Secondary Outcomes (1)

  • Metabolic adaptation in 24h energy expenditure

    24 weeks

Other Outcomes (2)

  • Sleeping energy expenditure

    24 weeks

  • Spontaneous physical activity

    24 weeks

Study Arms (3)

Self Directed Exercise

Participants randomized to the self-directed group will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss. Participants will not be given a specific exercise recommendation in terms of weekly energy expenditure.

Low Intensity Exercise

Individuals assigned to the low dose exercise group will be required to expend 8 calories per kg of body weight per week in structured aerobic exercise on a treadmill or stationary bicycle. The exercise intensity will be maintained at 65% of VO2peak. The caloric goal of each session will be calculated by dividing the weekly caloric expenditure goal by participant selected exercise frequency (i.e., 3, 4 or 5 times per week). The training program consists of a 3-min warm-up at a progressively increasing intensity until the prescribed training intensity is reached. All exercise sessions are conducted at the PBRC Fitness Center and will be supervised by staff trained on the aspects of the study protocol.

High Intensity Exercise

Individuals assigned to the low dose exercise group will be required to expend 20 calories per kg of body weight per week in structured aerobic exercise on a treadmill or stationary bicycle. The exercise intensity will be maintained at 65% of VO2peak. The caloric goal of each session will be calculated by dividing the weekly caloric expenditure goal by participant selected exercise frequency (i.e., 3, 4 or 5 times per week). The training program consists of a 3-min warm-up at a progressively increasing intensity until the prescribed training intensity is reached. All exercise sessions are conducted at the PBRC Fitness Center and will be supervised by staff trained on the aspects of the study protocol.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and Women enrolled in E-MECHANIC

You may qualify if:

  • Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2.

You may not qualify if:

  • Not enrolled in the E-MECHANIC main study (NCT#01264406).
  • Have a body mass index (BMI) less than 30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

MeSH Terms

Conditions

Weight LossMotor Activity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Leanne M Redman, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

December 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations